UDI requirements for medical devices: what healthcare organisations need to know

The Australian Government introduced the Australian UDI system to strengthen patient safety and improve medical device traceability. This system is part of broader medical device reforms outlined in An Action Plan for Medical Devices.

The UDI system supports the identification of medical devices and other medical device reforms. It is designed to improve the effectiveness of the regulatory framework, including management of post-market safety-related activities such as recalls.

Unique Device Identifiers (UDIs)

We require devices that are in scope of UDI requirements to be identified with a Unique Device Identifier (UDI).

UDIs must be provided in both human-readable and machine-readable formats. Machine-readable formats may include linear barcodes, Data Matrix barcodes or QR codes.

For more information on UDIs and other identifiers under the Australian UDI framework, see Understanding UDIs and related healthcare identifiers.

UDI requirements in Australia

Manufacturers and sponsors supplying medical devices in Australia are required to:

• assign a UDI to devices subject to UDI requirements
• place the UDI on device labels and packaging
• submit the UDI-DI and associated device information to the AusUDID.

Sponsors must also use UDI information, where available, in regulatory activities such as recalls and adverse event reporting.

UDI Triggers

Changes to certain characteristics of a device represent a new model of device. These are referred to as UDI Triggers.

When a new UDI-DI is required, the manufacturer must change the affected device labels to reflect the new UDI-DI and updated data must be supplied to the AusUDID. Data must be submitted to the AusUDID within 30 days of the newly labelled device being supplied in Australia.

When a new UDI-DI is required, the manufacturer must change the affected device labels to reflect the new UDI-DI and updated data must be supplied to the AusUDID. Data must be submitted to the AusUDID within 30 days of the newly labelled device being supplied in Australia.

Devices required to meet UDI requirements

Most medical devices and in vitro diagnostic (IVD) devices included in the Australian Register of Therapeutic Goods (ARTG) must comply with UDI requirements unless a specific exemption applies. UDI requirements are introduced according to device risk classification, with higher-risk devices required to comply first.

Class 1 IVDs categorised as follows must comply with the UDI regulations:

• Instrument/analyser IVDs (Global Medical Device Nomenclature (GMDN) Collective Term 943)
• Software IVDs (GMDN Collective Term 944).

Devices exempt from UDI requirements

Some devices are exempt from Australian UDI requirements.

Examples include:

• Class I non-sterile, non-measuring medical devices
• Class Im medical devices
• custom-made medical devices
• certain low-volume patient-matched medical devices
• devices supplied under the Special Access Scheme or Authorised Prescriber Scheme
• in-house IVDs
• certain Class 1 IVDs.

Manufacturers and sponsors may choose to apply UDIs to exempt devices, particularly where the device is required to meet UDI requirements in another country or jurisdiction. However, some exempt devices may not have a corresponding record in the AusUDID.

Some devices may be subject to UDI requirements, however, either be eligible for a transitional arrangement, or have TGA approved consent to supply. This means that while generally, that device would be required to meet UDI requirements, the sponsor has additional time before it is mandatory. In this case, devices may not bear UDI labels, may not have UDI records in the AusUDID, or both.

If you find a device that you expect should have a UDI, but it does not, you can contact the TGA at UDI@health.gov.au.

Where healthcare will see UDIs

Healthcare professionals may encounter UDIs in several locations depending on the type of device and how it is supplied.

Device labels

The UDI must appear on the device label and, where required, directly on the device itself. It must also appear on all applicable levels of packaging to support device identification throughout the supply chain.

The UDI must be provided in:

• human-readable form
• machine-readable form, such as a barcode, Data Matrix or QR code.

Device packaging

Different packaging levels require their own UDI-DI.

For example, a single device box, a carton and a case would each have a different UDI-DI.

Shipping containers, such as pallets, do not require a UDI.

Directly marked on the device

Some reusable medical devices may have the UDI directly marked on the device itself. This helps to identify the device after it has been separated from its packaging.

Examples of direct marking include laser etching and engraving.

Direct marking is not required for:

• implantable devices
• devices where direct marking is not technologically feasible
• devices where direct marking may affect safety or performance.

Patient Implant Cards (PICs)

Patient Implant Cards (PICs) provide patients with information about implanted medical devices and support future identification of those devices.

PICs must include:

• device name
• device model
• manufacturer details
• batch, lot number or serial number
• UDI-DI in human-readable form
• the full UDI (including the UDI-DI and UDI-PI) in machine-readable form.

How UDIs are included on PICs will depend on the manufacturer, sponsor, and healthcare provider. Some manufacturers will print the UDI directly on the PIC, whereas others will provide stickers or similar formats to be included.

Where healthcare may not see UDIs

Individual devices supplied in multipacks

Individual devices of the same model supplied in multipacks may not have the UDI on the individual device label, particularly where the individual packaging is too small to bear a label. In this case, the UDI is applied to the multipack and individual devices are assigned the Unit of Use DI.

Instructions for Use

The UDI is not required on Instructions for Use documentation, although some manufacturers may choose to include it.

Patient Information Leaflets

The UDI is not required on Patient Information Leaflets (PILs), although some manufacturers may choose to include it.

Devices where UDI is not yet mandatory

As UDI is being introduced in phases, and we allow for transitional arrangements and sponsors to obtain consent to supply, not every device will bear a UDI at once.

This also means that some devices that would otherwise be expected to meet UDI requirements have extra time due to the transitional arrangement or consent to supply.

If you encounter a device you think should be UDI compliant but is not, you can contact the TGA at UDI@health.gov.au.

UDI in reporting

UDI supports more accurate identification of affected devices during recalls, market actions and adverse event reporting.

Sponsors and manufacturers of medical devices with a UDI must include the UDI in reports.

Depending on the situation, reports may include:

• a UDI-DI to identify an affected device model, where the issue relates to the entire model of device
• a UDI-DI and UDI-PI to identify an affected batch or production run
• multiple UDI-DIs and/or UDI-PIs where several models and batches are involved.

Reports for devices exempt from UDI requirements will continue as per current practice and should include any applicable information.

UDI requirements by device type

In general, medical devices that are in scope of Australia's UDI requirements must carry a UDI on labels and packaging and have a corresponding UDI record in the AusUDID.

However, some device types have additional requirements or modified requirements because of how they are used in clinical settings. Understanding these differences will help healthcare organisations know whether a device should have a UDI and where to find it.

For full details on UDI requirements for specific device types, see: Complying with the Unique Device Identification requirements for medical devices.

Implantable devices

Implantable devices present some of the greatest opportunities to improve patient safety through UDI adoption.

Before implantation, healthcare providers should be able to identify the UDI of the device. The UDI for implantable devices will generally be available on the device label and packaging and may also be provided through peel-off labels, tags or other mechanisms that support recording the device information during procedures.

Implantable devices are not required to be directly marked with the UDI.

Implantable devices (unless specifically exempt) are required to include the UDI on the Patient Implant Card.

Single use devices

Single use devices are those that are used once and then discarded.

The location of the UDI depends on how the device is supplied.

• If devices are supplied in bulk and remain in their package until use, the UDI may appear only on the package. In this case, the devices may have a Unit of Use DI, to associate use of the device on a single patient.
• If devices are likely to be separated from the package before use, the manufacturer may place the UDI on the individual device packaging.

Reusable devices

Reusable devices are those that are reused, either on the same or different patients.

Manufacturers must directly mark the UDI onto reusable devices that are:

• used on multiple patients, and
• reprocessed through high-level disinfection or sterilisation between uses.

Direct marking helps ensure the device remains identifiable after repeated cleaning and sterilisation cycles.

Example: A reusable surgical scalpel may have its UDI permanently marked on the instrument itself so it can still be identified after reprocessing.

Capital equipment

Capital equipment includes large medical devices such as:

• MRI scanners
• CT scanners
• X-ray systems
• patient monitoring systems.

These devices must have a UDI, although the UDI does not usually need to be directly marked into the equipment.

Healthcare staff may see the UDI:

• on a durable equipment label
• on a metal identification plate
• on a sticker designed to withstand cleaning
• displayed electronically in the device software, such as within an ‘About’ screen.

Personalised medical devices

Personalised medical devices are designed, manufactured, adapted or modified to meet the needs of an individual patient. The TGA categorises PMDs into three groups:

• patient-matched medical devices
• adaptable medical devices
• custom-made medical devices.

The UDI requirements differ depending on the type of PMD.

Patient-matched medical devices (PMMDs)

Patient-matched medical devices are manufactured to match a patient's anatomy or clinical requirements using a validated design and manufacturing process.

PMMDs must meet UDI requirements when:

• the device is included in the ARTG
• more than five devices are manufactured per financial year, and
• the device falls within a UDI class that is in scope.

Where UDI requirements apply, healthcare providers should expect to see a UDI on the device label or packaging and be able to use the UDI for identification, traceability and patient record keeping.

Adaptable medical devices

Adaptable medical devices are mass-produced devices that are intended to be assembled, adjusted or adapted for an individual patient after supply, in accordance with the manufacturer's instructions.

Adaptable medical devices must meet UDI requirements where they are within the scope of UDI requirements.

Healthcare providers should expect these devices to carry standard UDI labelling and be included in the same traceability processes used for other regulated medical devices.

Custom-made medical devices

Custom-made medical devices are unique devices manufactured for a specific patient where the design cannot be fully validated using standard manufacturing methods. These devices are typically produced as a genuine one-off solution when no suitable alternative exists.

Custom-made medical devices are exempt from UDI requirements. Healthcare providers should not expect these devices to have a UDI or an associated UDI record.

Note that most of the devices that were previously supplied under the custom-made medical device exemption now meet the definition of PMMD.

Dental devices

Healthcare providers may encounter UDIs on:

• dental implants
• implant abutments
• other implantable dental devices.

Dental products that are exempt from ARTG inclusion are also exempt from UDI requirements.

Dental practitioners acting as sponsors must meet UDI requirements for implantable dental devices.

Medical devices that are software or incorporate software

For software products, healthcare users may see the UDI:

• on the medium itself, such as a CD
• in an 'About' screen or similar, easily accessible screen
• on installation media or packaging.

For devices containing embedded software, the UDI generally applies to the physical device rather than the software component alone.

Surgical loan kits

Surgical loan kits are commonly supplied to hospitals for specific procedures and often contain:

• reusable instruments
• implantable devices
• single-use devices.

The loan kit itself does not require a UDI. Instead, the individual devices within the kit must meet applicable UDI requirements.

Healthcare providers should expect manufacturers or kit suppliers to provide UDI information for component devices in a format that can be accessed during the procedure, such as:

• inventory sheets
• labels
• tags
• data strips.

We recognise there are challenges for SLK manufacturers to provide, and for healthcare to retain, the UDI-PI with small non-sterile devices in SLKS. These challenges include:

• Loss of UDI Carrier during sterilisation
  • Before surgery, small non-sterile devices are often sterilised and removed from their packaging or labelling, which could contain the UDI. Once separated from the UDI Carrier, the device may be difficult to identify later in the hospital or after the surgical loan kit is returned.
• Replenishment issues
  • When small non-sterile devices are replenished in a surgical loan kit, they may come from different production batches. This makes it difficult to maintain accurate production information and track individual components.
• Direct marking impracticalities
  • While direct marking is not required for implantable medical devices, industry advised that even if required, direct marking would be technically infeasible for small non-sterile devices due to their size.

To address these challenges, small non-sterile devices have reduced UDI requirements:

• Surgical loan kit manufacturers must provide the UDI-DI for small non-sterile devices that are supplied in a surgical loan kit
• Surgical loan kit manufacturers do not need to provide the UDI-PI for small non-sterile devices that are supplied in a surgical loan kit.

All devices must still be allocated a UDI-DI, and the UDI-DI must be easily accessible at the point of care.

Component manufacturers may voluntarily directly mark small non-sterile devices where technically feasible, enabling UDI-PI availability at point of care.

This means that small non-sterile devices may not have a full UDI. Where the UDI-PI is not provided for small non-sterile devices in a surgical loan kit:

• any market action, device incident report, or adverse event notification cannot be limited to a subset of production
• actions must include all production of the device with the relevant UDI-DI, and
• surgical loan kit manufacturers must extend regulatory actions to all surgical loan kits containing devices with that UDI-DI.

System or Procedure Packs (SOPPs)

A system or procedure pack (SOPP) is a collection of medical devices packaged together for a specific clinical purpose or procedure.

UDI requirements apply differently to the SOPP itself and to the individual medical devices contained within it.

A SOPP must have a UDI assigned to the pack when it contains one or more medical devices that are in scope. A SOPP does not require a UDI on the pack if it contains only:

• Class I medical devices (supplied non-sterile), or
• Class I medical devices with a measuring function (Class Im).

Individual components within the SOPP may have their own UDI, where they are sold separately.

Healthcare staff may see a UDI on the outer packaging of a SOPP when the pack includes devices that are subject to UDI requirements, as well as on individual components if required.

Systems or configurable devices

Some medical devices are supplied as systems. These are 2 or more goods that the manufacturer intends to be connected, used together or combined to achieve a specific medical purpose. They may be packaged together or separately.

Examples include:

• knee-joint replacement systems
• orthopaedic drill systems
• patient-monitoring systems with a monitor, power cable, and backup power supply.

Healthcare providers should expect systems as a whole to bear a UDI.

Some systems can also be configured. For configurable systems, a UDI-DI is allocated to defined groups of configurations the same way a UDI-DI is allocated to defined models of medical devices, and a UDI-PI is allocated to each individual system.

Accessories and replacement parts

Accessories may require their own UDI when they:

• are supplied separately from the parent device
• have their own ARTG inclusion
• are within scope of UDI requirements.

A simple replacement part, such as a screw, would generally not require a UDI unless it is supplied as a regulated medical device.

This means healthcare may or may not see UDIs for accessories, replacement parts or spare parts.

Devices principally sold in retail

Some devices are primarily sold through retail channels such as pharmacies and supermarkets.

These devices may use simplified UDI labelling arrangements. Healthcare providers may notice that devices principally intended for retail have less detailed UDI Carrier information than products intended primarily for clinical use.

If the same device later becomes primarily supplied to healthcare facilities, full UDI labelling requirements apply.

In vitro diagnostic (IVD) devices

UDI requirements apply to IVDs, including pathology and diagnostic test kits.

Healthcare providers will generally see the UDI on the outer packaging of the kit.

Individual consumables within the kit may not carry their own UDI where they are only intended to be used as part of that kit.

Key takeaway for healthcare providers

Healthcare providers should expect to encounter UDI information on:

• medical device labels
• packaging
• equipment identification plates
• software screens
• in some cases, directly on the device itself.

The specific presentation depends on the device type, but the purpose remains the same: to support accurate identification, traceability, patient safety, recalls and inventory management throughout the healthcare system.

Most devices will bear a UDI; however, some may not be required to due to not being supplied separately or regulated as a medical device in its own right. If you encounter a device you believe should have a UDI that does not, you can contact us at UDI@health.gov.au.